Resolution - RDC n. 46, of March 28, 2001

The Collegiate Board of Directors of the Brazilian Sanitary Surveillance Agency, in the use of the attribution vested in it by article 11, numeral IV, of the Regulation of ANVISA approved by Decree n.º 3.029, of April 16, 1999, combined with paragraph 1 of Article 111, numeral I, item " b ", of the Bylaws approved by Administrative Order n. 593, of August 25, 2000, republished in the Federal Official Journal of December 22, 2000, in meeting held on May 30, 2001,

whereas provisions set forth in Law n. 9.294, of July 15, 1996;

whereas provisions set forth in Federal Law n. 10.167, of December 27, 2000;

whereas provisions set forth in Law n. 9.782, of January 26, 1999, which determine the regulation, control and inspection of products and services that involve risk to public health;

whereas the significant increase of tobacco smoking that has caused, throughout the world, the loss of at least 3.5 million lives in 1998, with an estimated loss of 10 million every year until the year of 2030, 70% of which in developing countries;

whereas the world-wide recognition of the need to establish and control maximum levels of texts, nicotine and carbon monoxide of cigarettes;

whereas that the consumers of cigarettes do not distinguish the risks of exposure to high, average and low levels of tar, nicotine and carbon monoxide, thus making it necessary to extinguish the terminologies used for characterization of the said products, since, in addition to not enlightening consumers, they allow dubious messages in the advertising of these products;

has adopted the following Resolution of the Collegiate Board of Directors, applicable to tobacco products produced, transported, commercialized and/or stored in the national territory or imported, and I, Director-Chairman, determine its publication:

Article 1. Establish the maximum levels allowed of tar, nicotine and carbon monoxide present in the mainstream smoke of cigarettes commercialized in Brazil.

Paragraph 1. The reduction of the levels of tar, nicotine and carbon monoxide shall be done gradually, in compliance with the maximum deadlines indicated below, as from the date of publication of this Resolution:

I - 9 (nine) months for the maximum of 12 milligrams, 1.0 milligram and 12 milligrams, respectively for levels of tar, nicotine and carbon monoxide in each cigarette;

II - 18 (eighteen) months for the maximum of 10 milligrams, 1.0 milligram and 10 milligrams, respectively for levels of tar, nicotine and carbon monoxide in each cigarette.

Paragraph 2. The levels shall be measured according to the methods defined internationally by ISO (International Standards Organization) and acknowledged by ABNT - Brazilian Association of Technical Norms.

Article2. It is forbidden to use any denomination, in packings or advertising material, such as: class(es), ultra low level(s), low level(s), smooth, light, soft, moderate level(s), high level(s), and others that can induce the consumer to misinterpret the levels contained in cigarettes.

Only paragraph. The cigarette industries and importers shall be granted a period of 9 (nine) months, as from the date of publication of this Resolution, to adjust to the provisions set forth in this article.

Article 3. Determine the obligatory printing on cigarettes packings of the levels of tar, nicotine and carbon monoxide, with the following additional information: "there are no safe levels for consumption of these substances".

Paragraph 1. The printing referred to in the heading of this article shall indicate in full length, in legible form, on one of the sides of the packings, the respective levels, expressed in milligrams per cigarette, up to one decimal for nicotine, and in whole numbers for the tar and the carbon monoxide.

Paragraph 2. Packings are packs, boxes, packages and any other device for preservation of the product aimed at the consumer market .

Paragraph 3. The cigarette industries and importers shall be granted a period of 9 (nine) months, as from the date of publication of this Resolution, to comply with the provisions set forth in this article.

Paragraph 4. The products manufactured or imported prior to the period established in this article and distributed at the places of sale to consumers, may be commercialized until their final date of expiry.

Article 4. Failure to comply with the provisions set forth in this Resolution constitutes a sanitary infraction, rendering the offender liable to the penalties provided for in Law n. 6.437, of August 20, 1977 and in Federal Law n. 9.294 of July 15, 1996.

Article 5. This Resolution of the Collegiate Board of Directors enters into force on the date of its publication.

GONZALO VECINA NETO